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Research

Our specialists regularly oversee clinical research studies in an effort to contribute to the important area of women's healthcare. Through our research opportunities at NorthShore, we strive to provide our patients with access to leading edge treatment options not widely available elsewhere. 

The following studies are open to enrollment. If we are interested in learning more, please ask your physician, nurse or other care team member.

Gynecological Pain and Minimally Invasive Surgery Clinical Trials

Mechanistic Characterization of Uterine Pain to Improve Diagnosis and Treatment for Dysmenorrhea (M-CUP)
Aims: The purpose of this research is to discover the causes of menstrual pain. Additionally, we will study why a common over-the-counter NSAID helps or may not help with cramping pain.
Diagnosis: Women ages 18-45 who have primary dysmenorrhea (painful periods), endometriosis, or fibroids, and healthy controls with none of the aforementioned conditions
Principal Investigator: Kevin Hellman, PhD
Co-Investigator(s): Frank Tu, MD, MPH
IRB Approval Number: EH19-040
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes

Examining the Role of Improved NSAID Management in Treating Dysmenorrhea (NSAID)
Aims: The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder sensitivity changes from baseline after reduced menstrual pain experience.
Diagnosis: Women ages 18-45 who have primary dysmenorrhea (painful periods)
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH18-128
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes

Early Menstrual Pain Impact on Multisensory Hypersensitivity (EMPATHY)
Aims: The purpose of this study is to learn more about how menstrual pain affects pain sensitivity development, including at bladder and muscle sites, in girls pre-menarche and for 2 years following menarche.
Diagnosis: Healthy girls ages 10-14 who have not had their first period yet
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH17-338
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or thegyrl@northshore.org
Open to Enrollment: Yes

Noninvasive Imaging of Uterine Physiology to Improve Treatment for Dysmenorrhea
Aims: This study uses different MRI imaging methods to look at a woman's uterus to determine what may or may not be causing pain during menses.
Diagnosis: Women ages 18-45 with painful periods or chronic pelvic pain, and healthy controls
Principal Investigator: Kevin Hellman, PhD
Co-Investigator(s): Frank Tu, MD, MPH
IRB Approval Number: EH16-263
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes

 Interstitial Cystitis: Examination of the Central Autonomic Network (ICECAN)
Aims: The purpose of this study is to look at how brain circuits and the autonomic nervous system influence pain responses in women with Interstitial Cystitis/Bladder Pain Syndrome.
Diagnosis: Women ages 18-80 with bladder pain (IC/BPS) or myofascial pelvic pain (MPP), and healthy controls free of any pelvic pain
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH15-029
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes

Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain (CRAMPP)
Aims: The purpose of this study is to understand how the menstrual cycle and hormones affect a woman's level of pain sensitivity.
Diagnosis: Women ages 18-45 with painful periods (dysmenorrhea), bladder pain syndrome (BPS), or chronic pain, and healthy controls who do not have any of the aforementioned conditions
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH13-094
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes

Urogynecology Clinical Trials

Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective Randomized Trial
Aim: The purpose of this study is to determine whether a change in the volume of water that a woman can hold in her bladder can be used to determine whether treatment for interstitial cystitis, dimethyl sulfoxide and triamcinolone or bupivicaine/ heparin/triamcinolone mixture, is working.
Principal Investigator: Peter K. Sand, MD
IRB Approval Number: EH11-081
Contact: call 224.251.3493 with questions regarding the study.

A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse
Aim: The purpose of this research study is to compare two different standard of care treatments: a device (Uphold LITE) to a native tissue repair procedure for the treatment of symptoms for pelvic organ prolapse. Safety information and patient outcomes will be collected for three years and evaluated.
Principal Investigator: Peter K. Sand, MD
IRB Approval Number: EH13-301
Contact: call 224.251.3493 with questions regarding the study.

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence
Aim: The purpose of this study is to evaluate the safety and efficacy of a medical procedure in which your own muscle cells (AMDC-USR) are collected, processed, and then re-injected into the tissues of your urinary passage. This study will determine if the cells are safe and effective in treating stress urinary incontinence in females.
Principal Investigator: Peter K. Sand, MD
IRB Approval Number: EH13-455
Contact: call 224.251.3493 with questions regarding the study.

A Fidelity Measure for Pelvic Floor Physical Therapy in Female Pelvic Pain: A Validation Study
Aim: The purpose of this research study is to quantify the essential components of a pelvic floor physical therapy session and to determine the effect of adherence to a standard study protocol on patient reported outcomes of improvement.
Principal Investigator: Urogynecology fel
IRB Approval Number: EH15-282
Contact: call 224.251.2374 with questions regarding the study.

The Risk of Cognitive Impairment in Patients Starting Anticholinergic Medication to Treat Overactive Bladder: A Prospective Trial
Aim: With this study, we plan to describe the risk of cognitive decline in patients starting treatment with anticholingeric medications for overactive bladder.
Principal Investigator: Roger Goldberg, MD
IRB Approval Number: EH16-059
Contact: call 224.251.2374 with questions regarding the study.